CK NAC SL Clinical Chemistry Reagent, Elitech

Description

INTENDED USE
ELITech Clinical Systems CK NAC SL is an in vitro diagnostic reagent intended for the quantitative determination of creatine kinase (CK) in human serum and plasma samples on analyzers or semi-automatic analyzers.
This in vitro diagnostic device is for professional use only.

CLINICAL SIGNIFICANCE
Creatine kinase (CK) exists in 3 cytoplasmic forms:
CK-MM (dominant isoenzyme in striated and cardiac muscles), CK MB (mostly in cardiac muscle), and CKBB (only isoenzyme in brain).
Enzymatic activity of total creatine kinase is increased during muscle damage such as Duchenne dystrophy,
rhabdomyolysis, inflammatory diseases, myocardia infarction and trauma.
Certain antipsychotic drugs (olanzapine and quetiapine), and in some cases hypothyroidism, also trigger
elevated total CK activity.
Determination of total CK is used to help diagnose and to follow-up conditions associated with muscle
damage.

LIMITATION OF USE
The quantitative assay of creatine kinase (CK) alone cannot be used to diagnose a disease or a specific
pathology.
The results must be interpreted in conjunction with other diagnostic test results, clinical findings and the
patient’s medical history

COMPOSITION
Reagent 1 : R1
Imidazole buffer, pH 6.1 (20 °C)
D-Glucose 25 mmol/L
NADP 2.5 mmol/L
Hexokinase ≥ 6 800 U/L
Sodium azide < 0.1 % (w/w)

Reagent 2 : R2
Imidazole buffer, pH 8.9 (20 °C)
Creatine phosphate 250 mmol/L
ADP 15.2 mmol/L
G-6-PDH ≥ 8 800 U/L
Sodium azide < 0.1 % (w/w)
Also contains magnesium salts, N-acetyl cysteine,E DTA, diadenosine pentaphosphate and AMP for optimal performance.

MATERIALS REQUIRED BUT NOT PROVIDED
– CALI-0550 ELICAL 2
– CONT-0060 ELITROL I
– CONT-0160 ELITROL II
– Normal saline solution (NaCl 9 g/L).
– Analyzers or semi-automatic analyzers.
– General Laboratory equipment (e.g. pipette).
– Do not use materials that are not required as indicated above